Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

72 results for "Baxter Diagnostics, Inc."
1–24 of 72
Search insights Median review: 112d Cleared: 100% Top manufacturer: Baxter Diagnostics, Inc. Lead specialty: Microbiology
Cleared Jul 18, 1995
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K934458 · JWY
Baxter Diagnostics, Inc.
Microbiology · 673d
Cleared Apr 25, 1995
DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI
K950817 · JWY
Baxter Diagnostics, Inc.
Microbiology · 62d
Cleared Apr 14, 1995
DRIED GRAM-NEGATIVE MIC//COMBO PANELS
K935704 · LTT
Baxter Diagnostics, Inc.
Microbiology · 500d
Cleared Apr 11, 1995
STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY
K950570 · JLS
Baxter Diagnostics, Inc.
Chemistry · 67d
Cleared Mar 07, 1995
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K945235 · LTT
Baxter Diagnostics, Inc.
Microbiology · 131d
Cleared Feb 16, 1995
DRIED GRAM-NEGATIVE CEFPODOXIME
K941030 · LTT
Baxter Diagnostics, Inc.
Microbiology · 349d
Cleared Feb 08, 1995
LORACARBEF GRAM-NAGATIVE PANELS
K940917 · JWY
Baxter Diagnostics, Inc.
Microbiology · 348d
Cleared Feb 03, 1995
GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX
K941459 · JWY
Baxter Diagnostics, Inc.
Microbiology · 316d
Cleared Jan 31, 1995
DRIED GRAM NEGATIVE/CEFMETAZOLE
K941317 · JWY
Baxter Diagnostics, Inc.
Microbiology · 319d
Cleared Jan 09, 1995
DRIED GRAM-POSITIVE MIC/COMBO PANELS/CEFMETAZOLE
K942267 · JWY
Baxter Diagnostics, Inc.
Microbiology · 244d
Cleared Jan 09, 1995
MICRODILUTION/LORACARBEF PANELS
K942089 · JWY
Baxter Diagnostics, Inc.
Microbiology · 252d
Cleared Dec 02, 1994
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K943510 · JWY
Baxter Diagnostics, Inc.
Microbiology · 135d
Cleared Nov 22, 1994
DADE INNOVIN II
K935702 · GJS
Baxter Diagnostics, Inc.
Hematology · 357d
Cleared Nov 22, 1994
DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA
K935307 · DDQ
Baxter Diagnostics, Inc.
Hematology · 385d
Cleared Nov 22, 1994
STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY
K934003 · DKA
Baxter Diagnostics, Inc.
Toxicology · 462d
Cleared Nov 22, 1994
STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY
K933414 · KHQ
Baxter Diagnostics, Inc.
Chemistry · 497d
Cleared Nov 18, 1994
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K944651 · JWY
Baxter Diagnostics, Inc.
Microbiology · 53d
Cleared Oct 19, 1994
DRIED GRAM-POSITIVE MIC/COMBO PANELS, AMP/EXT DIL
K934323 · JWY
Baxter Diagnostics, Inc.
Microbiology · 411d
Cleared Aug 15, 1994
FLEXTRANS
K935987 · JSM
Baxter Diagnostics, Inc.
Microbiology · 244d
Cleared May 04, 1994
ANTITHROMBIN III CHROMOGENIC ASSAY
K936196 · JBQ
Baxter Diagnostics, Inc.
Hematology · 126d
Cleared Apr 26, 1994
PARAMAX ALCOHOL REAGENT
K934275 · DIC
Baxter Diagnostics, Inc.
Toxicology · 238d
Cleared Mar 11, 1994
PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS
K935568 · DLZ
Baxter Diagnostics, Inc.
Toxicology · 113d
Cleared Nov 26, 1993
PARAMAX(R) PHENYTOIN REAGENT
K932686 · DIP
Baxter Diagnostics, Inc.
Toxicology · 176d
Cleared Oct 28, 1993
DADE ANEMIA/HEMOCHROMATOSIS CONTOLS,LEVEL 1,LEVEL 2,AND LEVEL 3
K933437 · JJY
Baxter Diagnostics, Inc.
Chemistry · 106d